Neurizon Secures FDA Green Light and Full Funding for Late-Stage NUZ-001 ALS Trial

An announcement from Pharmaust Limited ( (AU:NUZ) ) is now available.

Neurizon reported a pivotal quarter marked by the US FDA lifting the clinical hold on NUZ-001’s IND and subsequently clearing the drug to enter the HEALEY ALS Platform Trial as Regimen I, positioning the asset at the centre of global ALS drug development and de-risking its path toward late-stage clinical evaluation. The company advanced manufacturing readiness with successful registration batches, strengthened long-term IP protection with a new Australian patent extending coverage for NUZ-001 to 2041, broadened its capital markets reach via OTCQB listing and US investor relations support, and secured a comprehensive funding package—combining placements, a strategic convertible note facility and an entitlement offer—alongside an R&D tax rebate to fully fund both phases of the HEALEY ALS Platform Trial and reinforce its balance sheet heading into 2026.

The most recent analyst rating on (AU:NUZ) stock is a Hold with a A$0.09 price target. To see the full list of analyst forecasts on Pharmaust Limited stock, see the AU:NUZ Stock Forecast page.

More about Pharmaust Limited

Neurizon Therapeutics Limited is an ASX-listed, clinical-stage biotechnology company focused on developing treatments for neurodegenerative diseases, led by its main drug candidate NUZ-001 for amyotrophic lateral sclerosis (ALS) and other indications such as Alzheimer’s, Huntington’s and Parkinson’s diseases. The company leverages partnerships, including a global licensing agreement with Elanco Animal Health, and operates with a global commercialisation outlook, supported by an expanding intellectual property portfolio and growing presence in North American capital markets.

Average Trading Volume: 470,999

Technical Sentiment Signal: Sell

Current Market Cap: A$76.31M

For an in-depth examination of NUZ stock, go to TipRanks’ Overview page.